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RecruitingNCT04207580PIN'SNPUpdated Mar 13, 2026

A National Prospective Cohort of Patients With Idiopathic Nephrotic Syndrome Beginning in Childhood.

An observational study in Idiopathic Nephrotic Syndrome, sponsored by University Hospital, Limoges. Recruiting at 48 sites in 2 countries. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-13.

Sponsored by University Hospital, Limoges · Observational

From the registry’s dates

  • Started Mar 2020; still recruiting 6 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,180
Ages
Up to 18 Years
Sex
All
01

Study summary

Pediatric idiopathic nephrotic syndrome (INS) is a rare disease for which the optimal therapeutic strategy has not yet been defined. A network of clinicians treating complicated forms of this disease (grouped within the Société de Néphrologie Pédiatrique, SNP) exists, but to date there is no prospective cohort following up these patients that would facilitate the development of cohort-nested trials. This absence of structured follow up makes it difficult to set up prospective studies.

The main objective is to create a prospective cohort of pediatric INS patients to collect cases treated in SNP centers, to study their epidemiological characteristics, and to provide a basis for comparison for future cohort-nested trials.

Read the detailed description

In this study, data from patients with INS will be recorded prospectively, regularly and systematically. The cohort will be composed of patients followed by pediatric nephrologists affiliated with the SNP. Metropolitan France, Reunion Island and Mayotte are the geographical areas concerned. It is planned to integrate other French overseas departments and territories, in particular the West Indies.

This is therefore a prospective, multicenter, cohort follow-up study. The data will be centralized via a secure website dedicated to the study.

Data will be obtained from:

  • Medical record data (hospitalization/consultations) as part of routine clinical follow-up for patients with active disease. This information will be medically validated and integrated into the database with the help of clinical research staff.
  • A telephone interview for annual follow-ups for patients whose absence of active disease no longer requires a systematic medical visit. This structured interview will be administered by telephone by the study's clinical research staff.
  • Self-administered or hetero-administered quality of life questionnaires (PEDS-QL), self-administered or hetero-administered treatment compliance questionnaires (Morisky's Score), and questionnaires on the aesthetic impact of treatments (Ferriman's Score). These questionnaires will be centralized and reported to the database by the study's clinical research staff.
02

Conditions studied

  • Idiopathic Nephrotic Syndrome

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Keywords

  • Cohort - Idiopathic nephrotic syndrome - child
03

In context

Nephrosis, Lipoid

75 studies on the registry are indexed under Nephrosis, Lipoid; 32 are open to participants now.

This study's planned enrollment of 1,180 is above the median of 283 across 28 observational studies indexed under Nephrosis, Lipoid.

Browse Nephrosis, Lipoid studies →

Lead sponsor

University Hospital, Limoges is the lead sponsor of 264 studies on the registry; 38 are open to participants now.

Browse University Hospital, Limoges studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric idiopathic nephrotic syndrome

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient under 18 years of age
  • With idiopathic nephrotic syndrome (according to SPN criteria) beginning after January 1, 2018
  • Child seen at least once in consultation or hospitalization by a pediatrician member of the Society of Pediatric Nephrology
  • Residing in France
  • Consent signed by parents and patient's agreement to participate (if of age)
  • Affiliated to a social security system.

Exclusion criteria

Exclusion Criteria:

  • Refusal of the patient or legal representatives to participate in the cohort
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,180 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Inclusion and follow up of pediatric patients

    Inclusion and follow up of pediatric patients with an idiopathic nephrotic syndrome, from the beginning of the disease to 18 years old or transfer of the follow-up to a nephrology unit for adults. 130 new patients are expected to be included on an annual basis.

    Other: Inclusion and follow up of pediatric patients with an idiopathic nephrotic syndrome,

Interventions

  • OtherInclusion and follow up of pediatric patients with an idiopathic nephrotic syndrome,

    The study consists in collecting clinical, biological, psychological and social data of INS pediatric patients. A bio collection is also created: blood, urine, hair and nails will be collected at the beginning of the INS (before starting immunosuppressive treatment).

06

What researchers measure

Primary outcomes

  1. Number of cases included in the cohort and description of their characteristics

    * Number of followed cases, gender, and age * Geographical localization of followed cases * Progressive disease pattern (relapses, corticosteroid dependence, other treatments used) * Serious side effects related to treatment

    Time frame: 2 years

07

Study locations

45 of 48 sites recruiting
08

References and documents

Publications

  • Bahans C, Boyer O, Dunand O, Parmentier C, Ranchin B, Roussey G, Samaille C, Tellier S, Vrillon I, Preka E, Meriguet T, Dubrasquet A, Ichay L, Clave S, Bernardor J, Merieau E, Dossier C, Guigonis V. A "Trial within a Cohort" platform for pediatric clinical trials on idiopathic nephrotic syndrome: scope, objectives, and design of the retrospective-prospective cohort PIN'SNP. Pediatr Nephrol. 2025 Jul;40(7):2225-2238. doi: 10.1007/s00467-025-06676-7. Epub 2025 Mar 3. PubMed 40032676 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2020 (actual). Primary completion is estimated for Jan 2030, 118 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2019
First posted
Dec 23, 2019
StartActual
Mar 13, 2020
Primary completionEst.
Jan 2030
CompletionEst.
Jan 2048
Last update
Mar 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04207580
Lead sponsor
University Hospital, Limoges
Responsible party
Sponsor
First posted
Dec 23, 2019
Start date
Mar 13, 2020
Primary completion
Jan 2030 (estimated)
Completion
Jan 2048 (estimated)
Last update
Mar 13, 2026

Study contacts

Vincent Guigonis, MD
Contact
vincent.guigonis@unilim.fr
+33 5 55 0563 58
Claire Bahans, PhD
Contact
claire.bahans@chu-limoges.fr
+33 5 55 05 63 58
Vincent Guigonis, MD
principal investigator · University Hospital, Limoges

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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